[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80821-80823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0266]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Study of Clinical
Efficacy Information in Professional Labeling and Direct-to-Consumer
Print Advertisements for Prescription Drugs; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of December 3, 2010 (75 FR
75477). The document announced a proposed collection of information
that has been submitted to the Office of Management and Budget (OMB)
for review and clearance under the Paperwork Reduction Act of 1995 (the
PRA). The document was published with an error. FDA, upon further
review, realized that 3 comments had been submitted in response to the
60-day notice and the responses to those comments are included in this
notice. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
[email protected].
SUPPLEMENTARY INFORMATION: In FR Doc. 2010-30385, appearing on page
75480, in the Federal Register of Friday, December 3, 2010, the
following correction is made:
On page 75480, in the third column, the last sentence in the sixth
complete paragraph states that no comments were received on the
paperwork burden for the 60-day notice that published in the Federal
Register of June 16, 2010 (75 FR 34142). FDA is correcting that
statement to read: Three comments were received that expressed support
for the research and recommended minor improvements to the study. The
responses to those comments are included in the following paragraphs.
(Comment 1) Several of this comment's suggestions have already been
incorporated into our study design. Specifically, we agree that the
study design should include the variables of age, education, ethnicity,
race, health literacy, and whether the respondent is currently being
treated with a prescription drug, and have included them in the
questionnaire. Also, we have contracted with an organization that
produces realistic ads and stimuli to ensure that we will show
respondents realistic materials.
Another question from this comment was the presentation of our
manipulations. To clarify, the specific format of the presentation will
be text only. We are investigating the use of charts and other visuals
in another study (FDA-2009-N-0263 (January 5, 2010), ``Presentation of
Quantitative Effectiveness and Risk Information to Consumers in Direct-
to-Consumer (DTC) Broadcast and Print Advertisements for Prescription
Drugs,'' OMB control number 0910-0663.) Because all of the respondents
in the current study will see the information in the same format, this
will not compromise our ability to answer the current research
questions.
The comment also recommends expanding the physician study to
include all health care professionals who have the ability to prescribe
(i.e., nurse practitioners and physician assistants). This is a good
idea, but it changes our research question from how physicians use
labels to how prescribers use labels. These groups vary in education
and may vary in experience and training in how to interpret and use
clinical trial data. Because we do not have a sample size that is large
enough to analyze differences between these groups, we will limit the
sample to physicians in this study.
Finally, the comment recommends that FDA publish findings from the
preliminary study related to the current project, ``Mental Models Study
of Health Care Providers' Understanding of Prescription Drug
Effectiveness'' (FDA-2008-N-0589; April 3, 2009). We agree
[[Page 80822]]
and have taken steps to publish this report on FDA's Division of Drug
Marketing, Advertising, and Communications Web site: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm.
(Comment 2) This comment had several suggestions regarding the
physician study. First, it recommended that we show physicians the
Prescribing Information (PI) in a manner consistent with how physicians
usually view sections of it, particularly since how each physician
views the PI may be highly individualized. We agree. Because there is
likely much variability in the way physicians view prescription drug
information, we have designed this part of the study to examine
specifically those habits. To do so, we will show physicians a
highlights section that is hyperlinked to the more complete sections of
the PI. We will record the order in which physicians access each
section and how much time they spend there. This will provide us with
information to gauge how physicians view the information in the PI,
something that we currently have no data on.
Second, this comment recommends that we show physicians final
magazine ads rather than conceptual ads. We agree and, as discussed in
the response to the previous comment, we have contracted with an
organization that produces professional-quality ads.
Third, this comment recommends increasing the sample size from 500
to 800 individuals. We agree that a larger sample would be desirable,
however, given resource constraints we are not able to increase the
sample size. Moreover, we have conducted a power analysis and have
determined that our current sample size is adequate to answer our
research questions.
Fourth, the comment recommends the removal of statements in the
questionnaire that the drug is fictitious and instead label it a
``potentially new drug.'' FDA had many internal discussions regarding
this issue and decided that because of the particular sample, it is
necessary to be upfront with them about the nature of the drug.
Physicians will be more savvy about the particulars of the chemical
entities and the realism of the clinical benefits and we do not wish to
make them skeptical of our purposes. We agree that this approach is
preferable for consumers and so we will inform them that this is a
potentially new drug in that part of the study.
Fifth, we agree that the characteristics of participants who are at
risk and those who are or are not treating with a prescription drug may
differ and we will include these variables in our analyses.
Sixth, the comment recommends altering question 17 of the
questionnaire to reflect the physicians' use of the DTC ad versus their
guess as to the understandability of the ad for patients. We agree that
we are asking physicians to estimate the level of understanding their
patients have. These perceptions are of specific interest to us as they
relate to physicians' perceptions of DTC advertising and of the
presentation of information in the ads. Physicians who have been in
practice for any length of time may have a sense of how their patients
will understand materials. This is a question that we will also
investigate in relation to the number of years physicians have been in
practice.
Seventh, the comment recommends that question 30 be split into two
questions to separately assess the effect of DTC advertising on
patients and the effect of DTC advertising on their practice. We agree
and will make that change.
This comment also had two suggestions for the consumer part of the
study. First, the comment recommended against delivering this study on
a handheld device, as the viewing of the ad may render the concept
unclear. We agree and have struggled with this issue, but due to the
constraints of the internet panel, we cannot specify the type of device
on which participants must take the survey. We have included a question
to assess this variable, and we will analyze it to determine if there
are sizable differences based on viewing medium.
Second, the comment recommends that the questionnaire avoid medical
terminology and reference to the ``prescribing information.'' We have
attempted to make the questionnaire clear for consumers and do not see
the word ``prescribing information'' in the questionnaire. The
questionnaire provided for comment includes programming notes that the
respondent will not see.
(Comment 3) First, this comment recommends evaluating the benefits
and risks together and in a similar format so as not to bias the
results. We agree that the benefits and risks should be evaluated
together and have several measures to investigate both. We are keeping
the risk information constant across all of our conditions specifically
so as not to bias the results. Our research questions involve the
conveyance of information about benefits. Because of the complexity of
DTC ads, we cannot manipulate both benefits and risks at the same time.
We are conducting other studies examining the presentation of risk
information (For example, FDA-2010-N-0417 (August 26, 2010),
``Experimental Study of Format Variations in the Brief Summary of
Direct-to-Consumer Print Advertisements'') and collectively, this body
of research will answer questions of benefit and risk presentation. To
clarify, risk information will be presented similarly to how it is
currently presented in DTC print ads.
Second, the comment recommends the introduction of a control arm
that is similar to what is currently being used in the marketplace. Our
design includes control conditions that do not present placebo
information. These ads will look identical to the ads for products that
are currently on the market.
Third, the comment questions the use of comparative benefit and
comparative safety questions. We are using these measures for
reliability as another way to assess consumers' perceived risk and
benefits. As recommended in the comment, we are using them for
informational purposes only and not as a specific, separate measure of
comparative advertising.
Fourth, the comment recognizes the complexity of the data that are
available to be conveyed in DTC ads. We agree that there are a number
of questions to be answered that cannot be addressed in the current
study: E.g., variations in clinical study designs, instruments used,
populations studied, and varying degrees of severity of illness. We
cannot address all questions in one study and have chosen to focus on
the issues of placebo and framing in a treatment and prevention
approach. We hope that the results of this study will spur additional
follow on studies conducted by FDA and others. Although the issue of
different therapeutic areas is also relevant, and a study looking at
the two ends of the disease-seriousness spectrum would be a great
follow on, the basic concepts of information processing should not
differ depending on drug class. Although we agree that replication is
valuable and necessary, we do not believe that limiting the study to
two therapeutic areas impugns the internal validity of the study.
Fifth, the comment recommends wording changes to the question about
taking the drug if the doctor prescribed it. Although we understand the
rationale for changing this question, it is a measure of behavioral
intention and as such, we wanted to have a more blunt measure of
intention. It will not be used to assess doctor-patient interaction
issues.
Sixth, the comment questions the inclusion of physicians in the
study, citing concerns that consumer responses
[[Page 80823]]
cannot be compared to physician responses and that this comparison is
not relevant to the regulation of DTC advertisements. Indeed, the
primary reason for conducting the study with physicians is to explore
their processing of the prescribing information (PI), wholly separate
from the consumer study. Nevertheless, since we have the two samples,
we are conducting some exploratory analyses to compare the responses of
consumers to information about a drug to the physicians' understanding
of the drug. While this does have relevance to the regulation of DTC
advertising (e.g., a DTC ad that features a presentation of information
that brings consumers closer to the assessment of the physician will be
preferred over that same ad with a presentation of information that
moves them farther away), we are approaching this comparison as a
first, exploratory attempt at this type of analysis.
Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32278 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P